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U.S. Department of Health and Human Services

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2003 Warning Letters

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Tobacco Retailer Warning Letters

 

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Warning Letters issued in 2003

 

* Not issued: A close-out letter may issue when, based on FDA’s evaluation, the firm has taken corrective action to address the violations contained in the Warning Letter. This procedure applies to Warning Letters issued on or after September 1, 2009.

* N/A: Not applicable, the Warning Letter was issued prior to September 1, 2009.

Read more about warning and close-out letters

 
Letter Issue Date Company Name Issuing Office Subject Close Out Date
September 29, 2003 Organon USA Inc. [ARCHIVED] New Jersey District Office GMP Finished Pharmaceuticals/Postmarketing/Reporting Adverse Drug Experiences/Adulterated N/A *
September 29, 2003 Cherry Point Seafood Company, Inc. [ARCHIVED] Atlanta District Office Seafood HACCP/Adulterated N/A *
September 26, 2003 LifeSouth Community Blood Centers, Inc. [ARCHIVED] New Orleans District Office GMP for Finished Pharmaceuticals/GMP for Blood & Blood Components N/A *
September 26, 2003 Westfalia-Surge, Inc. [ARCHIVED] Chicago District Office GMP for Finished Pharmaceuticals, Veterinary Drug/Adulterated N/A *
September 26, 2003 Horn's Feed Mill, Inc. [ARCHIVED] Chicago District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated/Misbranded N/A *
September 26, 2003 Target Your Health, Inc. [ARCHIVED] Center for Biologics Evaluation and Research Lacks Approved Biologics License Application/New Drug/Use of Ruminant Products N/A *
September 26, 2003 Greenvalley, LLC [ARCHIVED] New York District Office New Drug/False, Misleading Statements/Misbranded N/A *
September 25, 2003 America's Soup Company, Inc. [ARCHIVED] New Jersey District Office Seafood HACCP/Adulterated N/A *
September 25, 2003 Community Blood Bank of Erie [ARCHIVED] Philadelphia District Office GMP for Blood & Blood Components/Finished Pharmaceuticals N/A *
September 25, 2003 Ontonagon Memorial Hospital [ARCHIVED] Detroit District Office Mammography Quality Standards N/A *
September 24, 2003 Pride of Main Street Dairy LLC [ARCHIVED] Center for Food Safety and Applied Nutrition Food Labeling/Misbranded N/A *
September 24, 2003 Consolidated Machine Corporation [ARCHIVED] New England District Office Lacks Premarket Approval, Investigational Device Exemption/QSR/Misbranded/Adulterated N/A *
September 23, 2003 Universal Imaging Inc. [ARCHIVED] Detroit District Office Mammography Quality Standards N/A *
September 23, 2003 International Fine Foods [ARCHIVED] Minneapolis District Office Seafood HACCP/Adulterated N/A *
September 23, 2003 Garland Welding Supply Co. Inc. [ARCHIVED] Dallas District Office GMP in Mfr, Processing, Packing, Holding Drugs/GMP for Finished Pharmaceuticals/Adulterated N/A *
September 23, 2003 Chinle Comprehensive Health Care Facility [ARCHIVED] Los Angeles District Office Mammography Quality Standards N/A *
September 23, 2003 Henriksen Fisheries, Inc. [ARCHIVED] Minneapolis District Office Seafood HACCP/Adulterated N/A *
September 23, 2003 Susie-Q Fish Company, Inc. [ARCHIVED] Minneapolis District Office Seafood HACCP/Adulterated N/A *
September 19, 2003 Con-Cise Lens Company [ARCHIVED] San Francisco District Office Quality System Regulation/Adulterated N/A *
September 18, 2003 Giovanni's Aloha Foods, LLC [ARCHIVED] San Francisco District Office Food Labeling/Misbranded/Acidified Foods N/A *



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ICECI Warning Letters

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